The following data is part of a premarket notification filed by Pulsion Medical Systems Ag with the FDA for Pulsion Picco-2, Model 8500.
| Device ID | K072735 |
| 510k Number | K072735 |
| Device Name: | PULSION PICCO-2, MODEL 8500 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD. Wake Forest, NC 27587 |
| Contact | Jamie Sulley |
| Correspondent | Jamie Sulley PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD. Wake Forest, NC 27587 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2007-10-18 |